Parent U.S. patent application Ser. No. 821,567, filed Jan. 22, 1986, now U.S. Pat. No. 4,705,680 discloses dental creams stabilized against syneresis by the addition of a vegetable oil to the liquid vehicle.
Syneresis (liquid exudation from a paste product) is a serious consumer observable problem which will mar the cosmetic properties of a dentifrice. This effect is a serious problem in a paste product and is an even more serious problem in a self standing unit dose form.
Single unit dose forms of dentifrice, mouthrinse or other oral products have been considered desirable for many years. However, previous products such as a crushable tablet and a chewable but non crushable tablet did not appear to be acceptable to the consumer either practically or aesthetically.
The prior art discloses chewable shaped and molded unitary products for cleaning teeth and as a mouth freshener comprising gelatin, water, glycerin and a vegetable gum such as gum acacia as the gelling agent or binder for the other ingredients in U.S. Pat. No. 3,422,184. Other optional ingredients are included such as dental polishing agents, sweetening agents, antibacterial agents, flavoring agents, coloring agents and preservatives. No vegetable oil and no alginate crosslinked with a calcium ion is disclosed herein.
U.S. Pat. No. 4,060,602 discloses oral preparations for preventing dental caries containing about 0.03-1% by weight of pimento berry oil or terpeneless bay oil as the antimicrobial agent in dental compositions including lozenges or troches by mixing with mucilage or gelatin and water. Chewing gums containing a standard gum base may also be prepared with the antibacterial bay oil component. No crosslinked calcium alginate is disclosed herein, nor does the composition contain vegetable oil to control syneresis.
U.S. Pat. No. 4,525,342 also discloses a mouthwash or toothpaste containing vegetable oil to desorb microorganisms, in large amounts of 33-97% by weight of the oil phase. This product is delivered from a double squirt bottle, one compartment containing the oil phase and the other compartment containing an aqueous phase comprising water soluble conventional dental components such as alginate, saccharin, sodium monofluorophosphate, etc. This is totally different from present novel chewable single unit dose form containing an alginate crosslinked with calcium.
U.S. Pat. No. 4,157,386 discloses a soft chewable lozenge comprising a dry mixture of polishing agent, a fluoride ion source, a starch adhesive, an unsaturated vegetable oil as a viscosity builder and softening agent, and a non-cariogenic sweetener such as xylitol or sorbitol. No alginate crosslinked with a calcium ion is disclosed herein.
The use of sodium alginate both as a thickening agent in a gum base and as a hydrocolloidal coating for water-insoluble therapeutic agents is disclosed in U.S. Pat. No. 4,238,475, wherein is described a chewing gum capable of releasing therapeutic water-insoluble materials. The chewing gum comprises therapeutic particles precoated with a hydrocolloid such as gum arabic, dextrin, gum tragacinth, gelatin, pectin, carboxymethyl cellulose or alginate in a gum base containing two sweeteners, a plasticizer or aqueous softener in the form of a polyhydric alcohol-type syrup, and a thickener such as alginate, carrageenan, xanthan gums and other water-soluble gums, and a flavor derived from plants, leaves, etc. such as citris oils, peppermint oil, clove oil, bay oil and the like. There is no disclosure therein of alginate crosslinked with a calcium ion, which is the basis of present novel chewable tablet or lozenge.
U.S. Pat. No. 4,532,126 discloses a chewable filled soft elastic gelatin capsule, which includes a shell formed from a molten gel mass containing gelatin, water, plasticizer such as glycerin or sorbitol and an insoluble masticatory substance such as natural gums, rubber, paraffin, petroleum, wax, etc; and a filling material such as candy, breath fresheners, cough preparations and the like. The filling is incapsulated in the gel mass on conventional rotary die-encapsulation equipment. There is no disclosure of an alginate crosslinked with a calcium ion in the encapsulating gel mass.
European Pat. No. 0,181,179 discloses antimicrobial lozenge containing a cationic therapeutic agent and a solid nonionic lubricant such as hydrogenated vegetable oil prepared by mixing the flavor, therapeutic agent, filler (sorbitol) and lubricant and transferring the powder mixture to a tablet press to form tablets. No gelling agent is used in this composition, and the solid vegetable oil tableting lubricant constitutes 1% by weight of the composition.
Kelco Brochure, Structural Foods With the Algin/Calcium Reaction, Technical Bulletin F-83, January 1984, describes the formation of structured (gelled) foods with alginates via the algin/calcium reaction, using three major gelling methods. The diffusion setting method consists in allowing the calcium ions to diffuse slowly into an alginate solution using a two-mix system, i.e. a fruit/sugar mix is encapsulated with a thin coat of sodium alginate/sugar/water solution prior to immersing in an aqueous calcium/malic acid/sugar setting bath. The internal or bulk setting method consists in rapid mixing two mixes, one containing the alginate and the calcium ion source, dicalcium phosphate; and the other mix contains fruit puree, sequestrant and acid; and allowing the final mixture to set under shear-free conditions. The setting by cooling method consists in dissolving the alginate, calcium salt, acid and sequestrant in hot water and allowing the solution to set by cooling.
However, there is no disclosure of the use of the alginate/calcium gellation reaction in the formation of single unit dose dental products comprising an alginate crosslinked with a calcium ion, a flavor, vegetable oil, humectant and water. In addition, none of the three described processes of making structured (gelled) foods disclose present novel method of first forming shaped single dose discrete unit forms of the sodium alginate mixture which may contain all the dental components, or may be a shell surrounding a unit dose of active mouthwash; and then immersing said shaped unit forms into a setting bath containing a calcium ion source, rinsing said gelled unit forms, drying and packaging said unit dose forms.